National Cancer Institute; Notice of Closed Meetings, 49450-49451 [2012-20159]
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Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
with a check or money order payable to
‘‘SoCRA’’. Mail to: SoCRA (see Contact
for address). To register via the Internet,
go to https://www.socra.org/html/
FDA_Conference.htm. (FDA has verified
the Web site address, but we are not
responsible for any subsequent changes
to the Web site after this document is
published in the Federal Register.)
Payment by major credit card is
accepted (Visa/MasterCard/AMEX
only). For more information on the
meeting registration, or for questions on
the workshop, contact SoCRA (see
Contact).
The
public conference helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
What FDA Expects in a Pharmaceutical
Clinical Trial; (2) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (3) Part 11 Compliance—
Electronic Signatures; (4) Informed
Consent Regulations; (5) IRB
Regulations and FDA Inspections; (6)
Keeping Informed and Working
Together; (7) FDA Conduct of Clinical
Investigator Inspections; (8) Meetings
With FDA: Why, When, and How; (9)
Investigator Initiated Research; (10)
Medical Device Aspects of Clinical
Research; (11) Working With FDA’s
Center for Biologics Evaluation and
Research; (12) The Inspection Is Over—
What Happens Next? Possible FDA
Compliance Actions; (13) Ethical Issues
in Subject Enrollment; (14) Medical
Device Aspects of Clinical Research;
and (15) Are We There Yet? An
Overview of the FDA Good Clinical
Practice Program.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393), which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121) as outreach
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SUPPLEMENTARY INFORMATION:
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activities by Government Agencies to
small businesses.
Dated: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19852 Filed 8–15–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Issues in the Design of Clinical Trials
of Antibacterial Drugs for the
Treatment of Non-Cystic Fibrosis
Bronchiectasis; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop focusing on the design
of clinical trials of antibacterial drugs
for the treatment of non-cystic fibrosis
(non-CF) bronchiectasis. This public
workshop is intended to provide
information for, and gain perspective
from, health care providers, patients and
patient advocacy organizations,
academia, and industry on various
aspects of the design of clinical trials.
The input from this public workshop
will useful in developing topics for
further discussion.
Date and Time: The public workshop
will be held on September 7, 2012, from
8 a.m. to 3:30 p.m.
Location: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910. The hotel’s phone number is
301–589–0800. Seating is limited and
available on a first-come, first-served
basis.
SUMMARY:
interpreter or other special
accommodations should notify
Christine Moser or Lori Benner (see
CONTACT PERSON FOR MORE INFORMATION)
at least 7 days in advance.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM after submission of a
Freedom of Information request. Written
requests should be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet (https://
www.fda.gov/Drugs/NewsEvents/
ucm305463.htm) approximately 45 days
after the workshop.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop focusing
on scientific considerations in the
design of clinical trials of antibacterial
agents for the treatment of non-CF
bronchiectasis. Discussions will focus
on natural history; patient populations
for enrollment in clinical trials; current
standard of care and unmet need;
clinical trial endpoints, including
exacerbation and patient-reported
outcomes; and clinical trial design
elements, including duration of
treatment and patient followup.
FDA encourages individuals, patient
advocates, industry, consumer groups,
health care professionals, researchers,
and other interested persons to attend
this public workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20106 Filed 8–15–12; 8:45 am]
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CONTACT PERSON FOR MORE INFORMATION:
Christine Moser or Lori Benner, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6204,
Silver Spring, MD 20993–0002, 301–
796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early. Seating
will be available on a first-come, firstserved basis. To register electronically,
email your registration information
(including name, title, firm name,
address, telephone, and fax number) to
bronchiectasisworkshop@fda.hhs.gov.
Those without access to the Internet
may call 301–796–1300 to register.
Persons needing a sign language
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
E:\FR\FM\16AUN1.SGM
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Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Small
Grants for Behavioral Research in Cancer
Control.
Date: September 18–19, 2012..
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6130
Executive Blvd., Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Gerald G. Lovinger, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division Of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Room 8101, Bethesda,
MD 20892–8329, 301–496–7987,
lovingeg@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
REVIEW of P50 and R01 applications in
Lung, Skin, Ovarian, Pancreatic and
Gastrointestinal Cancers.
Date: September 19–20, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Caron A Lyman, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Room 8119, Bethesda,
MD 20892–8328, 301–451–4761,
lymanc@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
II.
Date: September 19–20, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Wlodek Lopaczynski, MD,
Ph.D., Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd. Room
8131, Bethesda, MD 20892, 301–594–1402,
lopacw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Emerging
Technologies in Biospecimen Science.
Date: October 24, 2012.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6116
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Donald L Coppock, Ph.D.,
Scientific Review Officer, Scientific Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH
6116 Executive Blvd., Room 7151 Bethesda,
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MD 20892 301–451–9385
donald.coppock@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Core
Infrastructure and Methodological Research
for Cancer Epidemiology Cohorts.
Date: October 31, 2012.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health 6120
Executive Blvd. Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Kenneth L. Bielat, Ph.D.
Scientific Review Officer, Special Review
Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Boulevard, Room 7147, Bethesda,
MD 20892–8329, 301–496–7576,
bielatk@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 13, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
49451
Conflict: Biodata Analysis and Biosystems
Modeling.
Date: September 12, 2012.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Kee Hyang Pyon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5148,
MSC 7806, Bethesda, MD 20892,
pyonkh2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurobiology of Integrative Brain
Functions.
Date: September 17, 2012.
Time: 2:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting)
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1236, zhaow@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
[FR Doc. 2012–20159 Filed 8–15–12; 8:45 am]
Dated: August 13, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2012–20158 Filed 8–15–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HOMELAND
SECURITY
Center for Scientific Review; Notice of
Closed Meetings
U.S. Citizenship and Immigration
Services
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
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[OMB Control Number 1615–NEW]
Agency Information Collection
Activities: Consideration of Deferred
Action for Childhood Arrivals, Form I–
821D, New Information Collection;
Emergency Submission to the Office of
Management and Budget; Comment
Request
30-Day Notice of Information
Collection Under Review.
ACTION:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS),
submitted the following emergency
information collection request, utilizing
emergency review procedures, to the
Office of Management and Budget
(OMB) for review and clearance in
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[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Pages 49450-49451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose
[[Page 49451]]
confidential trade secrets or commercial property such as patentable
material, and personal information concerning individuals associated
with the grant applications, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Small Grants for Behavioral Research in Cancer Control.
Date: September 18-19, 2012..
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6130 Executive Blvd.,
Rockville, MD 20852, (Telephone Conference Call).
Contact Person: Gerald G. Lovinger, Ph.D., Scientific Review
Officer, Special Review and Logistics Branch, Division Of Extramural
Activities, National Cancer Institute, NIH, 6116 Executive Blvd.,
Room 8101, Bethesda, MD 20892-8329, 301-496-7987,
lovingeg@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI REVIEW of P50 and R01 applications in Lung, Skin,
Ovarian, Pancreatic and Gastrointestinal Cancers.
Date: September 19-20, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Caron A Lyman, Ph.D., Scientific Review Officer,
Research Programs Review Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 6116 Executive Blvd., Room 8119,
Bethesda, MD 20892-8328, 301-451-4761, lymanc@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI SPORE II.
Date: September 19-20, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Wlodek Lopaczynski, MD, Ph.D., Scientific Review
Officer, Research Programs Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 6116 Executive Blvd.
Room 8131, Bethesda, MD 20892, 301-594-1402, lopacw@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Emerging Technologies in Biospecimen Science.
Date: October 24, 2012.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6116 Executive Boulevard,
Rockville, MD 20852, (Telephone Conference Call).
Contact Person: Donald L Coppock, Ph.D., Scientific Review
Officer, Scientific Review and Logistics Branch, Division of
Extramural Activities, National Cancer Institute, NIH 6116 Executive
Blvd., Room 7151 Bethesda, MD 20892 301-451-9385
donald.coppock@nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Core Infrastructure and Methodological Research for Cancer
Epidemiology Cohorts.
Date: October 31, 2012.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health 6120 Executive Blvd.
Rockville, MD 20852, (Telephone Conference Call).
Contact Person: Kenneth L. Bielat, Ph.D. Scientific Review
Officer, Special Review Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116 Executive Boulevard,
Room 7147, Bethesda, MD 20892-8329, 301-496-7576,
bielatk@mail.nih.gov.
Information is also available on the Institute's/Center's home
page: https://deainfo.nci.nih.gov/advisory/sep/sep.htm, where an
agenda and any additional information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: August 13, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-20159 Filed 8-15-12; 8:45 am]
BILLING CODE 4140-01-P
